eTMF Solutions Architect — Global Clinical Compliance

Excelya; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Excelya is seeking an eTMF Specialist to ensure quality, compliance, and inspection readiness of the electronic Trial Master File across global trials. The role requires expertise in clinical documentation management, collaboration with cross‑functional teams, and active involvement in audits within a regulated environment, with a focus on ICH‑GCP and regulatory standards.

You will lead Veeva Vault TMF configurations, validation activities, data migrations, and training to enable seamless study

Qualifications

• Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related field.
• Strong experience in clinical trial documentation management.
• Hands-on experience with Veeva Vault TMF (mandatory).
• Strong understanding of the DIA TMF Reference Model.
• Experience with TMF metrics, KPIs, and dashboards.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Understanding of clinical trial documentation lifecycle.
• Knowledge of cross-functional stakeholders (Clinical, QA, PV, Biometry, etc.).
• Excellent collaboration and communication skills across global teams.

Responsibilities

• Led implementation and configuration of Veeva Vault Clinical apps (eTMF, CTMS, SSU, Payments, Site Connect).
• Facilitated requirements workshops and translated business needs into compliant system solutions.
• Designed and configured Vault solutions aligned with clinical operations and regulatory requirements.
• Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation.
• Oversaw data migration and system integration projects, ensuring data quality and interoperability.
• Developed and delivered end-user and administrator training programs for user adoption.
• Advised stakeholders on best practices, configuration options, and optimization of processes.
• Partnered with client project teams to ensure delivery and compliance with ICH-GCP and GxP standards.

Skills

Veeva Vault TMF

DIA TMF Reference Model

TMF metrics & dashboards

ICH/GCP regulatory knowledge

Clinical trial documentation lifecycle

Cross-functional collaboration

Audit & inspection readiness

Education

Bachelor’s or Master’s degree in Health Sciences/Life Sciences

Tools

Veeva Vault TMF

Job description

Excelya is seeking an eTMF Specialist to ensure quality, compliance, and inspection readiness of the electronic Trial Master File across global trials. The role requires expertise in clinical documentation management, collaboration with cross‑functional teams, and active involvement in audits within a regulated environment, with a focus on ICH‑GCP and regulatory standards.

You will lead Veeva Vault TMF configurations, validation activities, data migrations, and training to enable seamless study